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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer NexGen Augment

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 Class 2 Device Recall Zimmer NexGen Augmentsee related information
Date Initiated by FirmApril 02, 2015
Date PostedMay 01, 2015
Recall Status1 Terminated 3 on September 23, 2015
Recall NumberZ-1575-2015
Recall Event ID 71009
510(K)NumberK960279 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductNexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur.
Code Information Part #00-5990-036-10;  lot 62815809
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information ContactConsumer Relations Call Center
800-447-5633
Manufacturer Reason
for Recall		The affected lot is being recalled because it was packaged without the locking screw. The locking screw packaged with the augment is used to fix the augment to the femoral component. This has the potential to delay surgery
FDA Determined
Cause 2		Mixed-up of materials/components
ActionOn 4/2/2015, URGENT MEDICAL DEVICE RECALL LOT SPECIFIC notifications were sent to the affected distributors with instructions for locating, quarantining, and returning the affected product. All distributors were notified via electronic mail, and distributors with affected inventory were also notified via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.
Quantity in Commerce20 units
DistributionDistributed in the states of IN, MN, FL, and IL, and the countries of Argentina and Germany.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JWH
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